VolitionRx Limited, Isnes, Belgium,has announced interim results from its first asymptomatic colorectal cancer frontline screening study. The ongoing study is being carried out in collaboration with Hvidovre Hospital at the University of Copenhagen, and involves 680 subjects from the Danish national colorectal cancer screening program.

The interim results demonstrated that the Nu.Q panel—a small panel of three enzyme-linked immunosorbent assays—when considered with the subjects’ ages and smoking histories, produced an area under the curve of 83% and was able to detect 80% of Stage I colorectal cancer cases and 66% of high-risk adenomas at 78% specificity, respectively.

“After 7 years of hard work, we are happy to announce these excellent early detection interim results from our ongoing frontline screening trial for colorectal cancer,” says Cameron Reynolds, chief executive officer of VolitionRx. “Using only a small panel of three assays and considering certain limited patient variables, these data demonstrate that we can identify early-stage and precancerous adenomas at a high level of accuracy in an asymptomatic screening environment. Our tests use only a small amount of blood and could be added to routine blood screening regimens at a reasonable cost.”

According to Reynolds, the company hopes that its Nu.Q panel will form the basis of new colorectal cancer tests with early-stage disease detection to be used globally. VolitionRx plans to validate the results in a 4,300-subject study, and subsequently in a 12,000-subject double-blinded study, using samples collected at 10 collaborating Danish hospitals.

Hans Jorgen Nielsen, MD, Hvidovre Hospital.

Hans Jorgen Nielsen, MD, Hvidovre Hospital.

“These interim results are encouraging, particularly for detecting early-stage colorectal cancer and potentially precancerous adenomas,” says Hans Jorgen Nielsen, MD, professor of surgical oncology at Hvidovre Hospital. “Most blood-based cancer biomarkers are more effective at detection of large late-stage cancers than small early-stage cancers, and very poor at detecting precancer.”

In the United States, VolitionRx is participating in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s early detection research network, with a cohort of more than 13,500 subjects. Collection is under way and is expected to be completed in 2020. The objective is to build upon European studies to refine test performance and to present final data to FDA prior to completion of the study. VolitionRx expects to define the final panel for the US frontline test within the next 18 months.

Photo Micallef Jake

Jake Micallef, PhD, VolitionRx.

“We have now embarked with confidence on our next stage of assay development to further validate these assays and, ultimately, our Nu.Q frontline asymptomatic colorectal cancer screening test,” says Jake Micallef, PhD, chief scientific officer at VolitionRx. “This will be run in parallel with ongoing work in our 680-sample set, which still has more Nu.Q assays to be tested.”